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NCT06330805 · ClinicalTrials.gov registry record · Phase 2

Effects of Relugolix vs Leuprolide on Cardiac Function in Patients With Prostate Cancer

A Phase 2 study of Prostate Adenocarcinoma and Stage IIC Prostate Cancer AJCC v8, sponsored by Ohio State University Comprehensive Cancer Center.

Recruiting
Registry status
Phase 2
Development phase
70
Enrollment target
1
Study location

NCT06330805: Recruiting Phase 2 study of Prostate Adenocarcinoma and Stage IIC Prostate Cancer AJCC v8, sponsored by Ohio State University Comprehensive Cancer Center.

NCT06330805 is a Phase 2 study of Prostate Adenocarcinoma and Stage IIC Prostate Cancer AJCC v8 that is actively recruiting participants, run by Ohio State University Comprehensive Cancer Center. The registered enrollment target is 70 participants, below the 218-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (68% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06330805, a Phase 2 study of Prostate Adenocarcinoma and Stage IIC Prostate Cancer AJCC v8, is actively recruiting participants, sponsored by Ohio State University Comprehensive Cancer Center.

RECRUITING
Registry status
Phase 2
Development phase
70 participants
Enrollment target
1
Study location

Study Summary

This phase II trial compares the effect of relugolix to leuprolide on cardiac function and performance in patients with prostate cancer. Androgen deprivation therapy (ADT) has been a key component for the treatment of advanced prostate cancer for decades. The term androgen deprivation therapy means lowering a man's testosterone. Long-term studies show that ADT may contribute to a detriment to cardiac health and predisposes men to developing cardiac diseases. Recent studies suggest that men taking relugolix for treatment of prostate cancer may have a lower risk of developing cardiovascular problems, but more studies are needed to understand this observation, and there are currently no studies reporting the direct impact of ADT (relugolix, versus the more-commonly used leuprolide) on cardiac function and outcomes. Participants will receive definitive radiotherapy for unfavorable intermediate risk prostate cancer and 6-month ADT (either relugolix or leuprolide). In addition, participants will undergo the following: 1. Comprehensive cardiac and exercise testing before and after starting ADT 2. Completion of quality-of-life questionnaires at specific intervals during the study period 3. Provide blood samples at specific intervals during the study period to test for changes in steroid levels and certain biomarkers

Primary Outcome

We will measure the difference in myocardial perfusion with exercise stress-rest cardiac MRI before and after ADT (leuprolide vs. relugolix).

Conditions Studied

Prostate Adenocarcinoma Stage IIC Prostate Cancer AJCC v8 Stage IIB Prostate Cancer AJCC v8

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Magnetic Resonance Imaging
  • OTHER Contrast Agent
  • OTHER Physical Performance Testing
  • DRUG Leuprolide

Study Locations (1)

Ohio

  • Ohio State University Comprehensive Cancer Center - Columbus

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2024-08-12
Est. Completion 2027-12-31
Phase Phase 2
Ohio State University Comprehensive Cancer Center

341 total trials

What NCT06330805 shows while recruiting

NCT06330805 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 218-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (68% lower).

The record links to 3 conditions, with Prostate Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT06330805 reports a single indexed study location in Ohio.

Frequently Asked Questions

What is clinical trial NCT06330805 about?

NCT06330805 is a clinical study titled "Effects of Relugolix vs Leuprolide on Cardiac Function in Patients With Prostate Cancer". This phase II trial compares the effect of relugolix to leuprolide on cardiac function and performance in patients with prostate cancer. Androgen deprivation therapy (ADT) has been a key component for the treatment of advanced prostate cancer for decades. The term androgen deprivation therapy means ...

What is the current status of trial NCT06330805?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2024-08-12. Estimated completion is 2027-12-31.

What conditions does trial NCT06330805 study?

This clinical trial studies the following conditions: Prostate Adenocarcinoma, Stage IIC Prostate Cancer AJCC v8, Stage IIB Prostate Cancer AJCC v8.

What interventions are being tested in trial NCT06330805?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Contrast Agent (OTHER), Physical Performance Testing (OTHER), Leuprolide (DRUG).

Who is sponsoring clinical trial NCT06330805?

This trial is sponsored by Ohio State University Comprehensive Cancer Center, which has 341 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06330805 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Prostate Adenocarcinoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06330805's enrollment target sits among peer trials

70 52nd of 99 higher than 48 of 99 other Prostate Adenocarcinoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Prostate Adenocarcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06330805

Source: ClinicalTrials.gov NCT06330805, the US trial registry maintained by the National Library of Medicine. NCT06330805 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.